The continuous need for new and better medical treatments results in the performing medication of today. Economic and social importance constantly push the pharmaceutical sector to create the most effective medicine possible. The following factors represent main influence in the final effect of a treatment:    1. The characteristics of the medicine per dose. Clinical trials are executed to study and determine the most adequate molecules and their necessary concentrations to cure the patient properly.    2. The timely administration of the medicine (with a frequency recommended by the manufacturer, the pharmacist or on doctor's orders) which is strongly depending on the patient's adherence.
Recent studies made by order of the World Health Organization show the importance of the second factor, namely the patient's compliance. Half of the actual administered medicine does not lead up to an effective treatment due to lack of adherence, despite the good intrinsic quality of the medicine. It is clear that this problem has an enormous impact world-wide both on social and on economic level.
These studies conclude that there is an urgent need for a modern solution to this problem. The present invention offers an answer based on a new concept.
Up to date, there exists some electric communication devices which solve partially the problem of the compliance of the patient.
For example, U.S. Pat. No. 4,708,716 discloses an applicator for a transdermal drug delivery medication comprising an electric circuitry which is closed by the skin when the applicator is applied to the skin. This application causes the current to flow and the medicament to move through the skin into the blood stream. An electrode may be employed in a loop circuit to feedback a signal when a desired dosage level is achieved in the blood stream, so that with such feedback loop, a demand type applicator is achieved which regulates the drug dosage as desired. An LCD or an electrochemical phototropic material (ECM) may be incorporated in the circuitry of the device to serve as an indicator. With completion of the circuit, the indicator is activated so as to provide a positive indication that the drug is being delivered transdermally.
Unfortunately, such a device is restricted to transdermal drugs and is difficult to manufacture. Indeed, the operating of the device is associated with the transfer through the skin of a liquid medicine which will migrate to the skin from the drug reservoir upon the effect of the current flow. Therefore, the system requires the construction of a drug reservoir, having electrodes to force the drug to migrate and the construction of an electric circuitry which will be closed by the skin. Therefore, if a small portion is not well applied onto the skin, the closing of the circuitry will not occur and the device will not operate properly.
Moreover, the device according to U.S. Pat. No. 4,708,716 confirms the patient that the diffusion of the drug has correctly occurred with a transmission of a luminous signal which can cause troubles in some environments like hospital surrounding or the like. Such a luminous signal is not perceptible when the wearer of the device is sleeping. Therefore, it can happen that the medicine is not correctly taken by the patient, for example during the night or when busy with a task asking concentration. By providing a confirmation with a positive indication that the drug is being delivered transdermally, the device does not inform the patient of a dysfunction and the patient should be attentive to check if the signal has been emitted by the device.
Further the device according to U.S. Pat. No. 4,708,716 is only usable on the patient himself or herself.
Another example is given in U.S. Pat. No. 6,175,763. The electrotransport system according to U.S. Pat. No. 6,175,763 comprises a drug reservoir for delivering drug upon the effect of a electrotransport drive current through the skin. The electrotransport system comprises a sensor for sensing a condition or an event associated with the operation of the system, a controller and a tactile signal generator for generating a tactile signal which can be sensed. In particular, the sensor is a pH sensor which senses the pH of the drug in the reservoir or a sensor which senses the drug content in the reservoir. If a problem occurs in the device, such an abnormal pH or an abnormal content in the reservoir, for example an empty reservoir, the controller which is provided to receive the signal from the sensor and to control the tactile signal generator, detects an abnormal value and a tactile signal is transmitted to the skin of the patient.
Such a device resolves partially the problems of the device of the U.S. Pat. No. 4,708,716 by providing a tactile signal which can be sensed when the patient is sleeping or busy. The tactile signal is only transmitted to the patient's skin when a problem occurs and no signal will be transmitted when the device has correctly operated.
Unfortunately, such a device is also only applicable in a transdermal drug application, as the operating is associated with the migration of the drug from the reservoir. The tactile signal is also associated with the functioning, in particular with a dysfunctioning of the device. The device is also difficult to manufacture as it is required the presence of a drug reservoir comprising a liquid drug and captors, like level captor or pH captor and an electric circuitry.
The electric circuitry is also closed by the skin of the wearer and if the device is not well applied, the device will not correctly function and a tactile signal shall be generated. Moreover, the device according to U.S. Pat. No. 6,175,763 is only usable on the patient himself or herself.
Indeed, the devices according to both US patents should be manufactured with the drug contained in a reservoir and should comprise an electronic or electric circuitry. Therefore, the manufacturing steps are not easy and the resulting device is expensive. Moreover, such device can alert the patient about a dysfunction of the device but does not solve the problem of the timely administration of the medicine for example a tablet medicine or a pill medicine or even an injection medicine (with a frequency recommended by the manufacturer, the pharmacist or on doctor's orders) which is strongly depending on the patient's adherence.
Another kind of electric communication device exists. For example, the electric communication device described in the GB 2 386 207. The device of GB 2 386 207 is disclosed in the preamble of claim 1. It is a silent anatomic alarm system comprising an emitter wireless base unit and an anatomic wireless unit (electric communication unit). The anatomic wireless unit is able to output an electric current onto the skin of the user on receipt of a signal transmitted from the base unit. Such an electric communication system is, for example provided to remind the patient that he or she has to take his or her pill, tablet, etc. or to make his or her injection. This device consists of two rings connected together, and provided to be respectively fastened, for example on a user's foot and on the user's ankle. This device can find a utility in medication that were not transdermally applied, such as tablets, pills, etc. and can be applied to another person than the patient, but this device is bulky and not operable outside the transmission range from the base unit.
Therefore, known electric communication units have thus important limitations at several levels: too large, poor user-friendlyness, not easy to manufacture, no possibility to alert independently of the user's conditions, poor discretion, only applicable for specific types of medicine, not conceived for easy addition to existing medicament packaging and the like.
It is an object of the invention to palliate at least some of these drawbacks by providing a broad applicable concept which improves reliability by alerting the patient that he or she has to take his or her medicine and which can be applied on the skin of another person while being independent of the user conditions.